NCT06605378 Prevalence of Antibodies and Cytokines in Participants With Chronic Granulomatous Disease
| NCT ID | NCT06605378 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ensoma |
| Condition | Chronic Granulomatous Disease (CGD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-11-18 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.
Eligibility Criteria
Inclusion Criteria: * The participant must have been diagnosed with CGD based on the referring physician's confirmation that NADPH oxidase activity is ≤5% (i.e., the percentage of dihydrorhodamine-positive \[DHR+\] cells is ≤5% by flow cytometry) OR based on confirmed pathogenic mutation in a CGD associated gene (CYBB, CYBA, NCF1, NCF2, NCF4, or CYBC1). * The participant or the participant's legally authorized guardian or representative (if applicable) must be capable of giving signed informed consent. * The participant (with assistance from the participant's legally authorized guardian/representative or primary caregiver, if applicable) must be capable of complying with the requirements and restrictions listed in the protocol and informed consent form (ICF). Exclusion Criteria: * The participant has undergone an allogeneic bone marrow transplant or investigational gene therapy. * The participant is unable to comply with the sample collection procedure based on investigator judgment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06605378 clinical trial?
This trial is open to participants of all sexes, studying Chronic Granulomatous Disease (CGD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06605378 currently recruiting?
Yes, NCT06605378 is actively recruiting participants. Contact the research team at ddietz@ensoma.com for enrollment information.
Where is the NCT06605378 trial being conducted?
This trial is being conducted at Montgomery, United States, Phoenix, United States, Little Rock, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT06605378 clinical trial?
NCT06605378 is sponsored by Ensoma. The trial plans to enroll 60 participants.